510(k) · Cleared
ClearedVitek 2 Gram Positive Vancomycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Oct 15, 2007 as substantially equivalent to K050075 (bioMerieux, Inc., 2005) after a 24-day review. Its family tree reaches back 2 generations to 2003. 4 later devices descend from it.
- Decided
- Oct 15, 2007
- Review
- 24 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032766 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK032766 Vitek 2 Gram Positive LinezolidbioMerieux, Inc. · 2003
- 1 generation backK050075 Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2005
- This deviceK072668 Vitek 2 Gram Positive VancomycinbioMerieux, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK091126 Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK230864 VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2…bioMerieux, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK234000 VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK093076 Vitek 2 Gram Positive DoxcyclinebioMerieux, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K091126Vitek 2 Gram Positive DaptomycinbioMerieux, Inc. · 2009 · cites it directly3descendants
- K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…bioMerieux, Inc. · 2023 · 2 generations on1descendant
- K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc. · 2024 · 3 generations on0descendants
- K093076Vitek 2 Gram Positive DoxcyclinebioMerieux, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032766 | Vitek 2 Gram Positive Linezolid | bioMerieux, Inc. | 2003 | — |
| −1 | K050075 | Vitek 2 Gram Positive Daptomycin | bioMerieux, Inc. | 2005 | — |
| 0 (this device) | K072668 | Vitek 2 Gram Positive Vancomycin | bioMerieux, Inc. | 2007 | — |
| +1 | K091126 | Vitek 2 Gram Positive Daptomycin | bioMerieux, Inc. | 2009 | — |
| +2 | K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP… | bioMerieux, Inc. | 2023 | — |
| +3 | K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | 2024 | — |
| +2 | K093076 | Vitek 2 Gram Positive Doxcycline | bioMerieux, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050075 | Vitek 2 Gram Positive DaptomycinSummary page 1…21 CFR 866.1645 Common Name: VITEK 2 AST-GP Vancomycin C. Predicate Device: VITEK 2 Gram Positive Daptomycin (K050075). D. 510(k) Summary: VITEI ® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enteroco… | 2005 |
| † | K050002 | Vitek 2 Compact | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091126 | Vitek 2 Gram Positive Daptomycin | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091126 (bioMerieux, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K050075.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative test. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used…
Read the full statement (105 words)
VITEK® 2 Gram Positive Vancomycin is designed for antimicrobial susceptibility testing of Enterococcus species, Staphylococcus species and Streptococcus agalactiae. VITEK 2 Gram Positive Vancomycin is a quantitative test. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK ®2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072668 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072668: Vitek 2 Gram Positive Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072668
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026